Recombinant Human Follicle Stimulating Hormone(Beijing SL Pharmaceutical Co., Ltd.)

To validate the efficacy of salvage hormonal therapy in men with non‐obstructive azoospermia at their second microdissection testicular sperm extraction.

This was a multi‐institutional study registered at the Japanese University Hospital Medical Information Network clinical trial center. After 1 month of human chorionic gonadotropin therapy (5000 IU, three times a week), patients were treated with recombinant human follicle‐stimulating hormone (150 IU, three times a week) and human chorionic gonadotropin for the next 3 months. Three testicular samples were obtained randomly from both testes, and sent for pathological diagnosis at the first and second microdissection testicular sperm extraction.

A total of 21 men, excluding those with chromosomal abnormalities, azoospermia factor a or b deletions, extremely small testes (<2 mL), or prior hormonal therapy, were eligible to participate based on our inclusion criteria. At the first microdissection testicular sperm extraction, 13 and six patients had Sertoli cells only and an early maturation arrest, respectively. With the second microdissection testicular sperm extraction, sperm were successfully obtained from two patients (10%). Patient age, testicular volume and hormone profiles were not associated with the results of the second microdissection testicular sperm extraction. However, the testicular histology of the two successful patients were late maturation arrest and hypospermatogenesis.

Effectiveness of human chorionic gonadotropin‐based salvage hormonal therapy preceding a second microdissection testicular sperm extraction seems to be limited. Non‐obstructive azoospermia men who have differentiated cells in their testes are likely to respond to hormonal stimulation.

Follicle‐stimulating hormone plays a crucial role in spermatogenesis. The aim of this study was to evaluate the efficacy of treatment with FSH in Chinese infertility population.

Prospective, randomized, double‐blind, placebo‐controlled clinical study.

A total of 354 men affected by idiopathic oligozoospermia from three medical centres.

This study contained three parts: (i) treatment with different doses of rhFSH (50 IU, 100 IU, 200 IU and 300 IU); (ii) the efficacy of rhFSH at different periods (2, 3, 4, 5 months); (iii) FSH treatment in patients with different levels of inhibin B (normal‐level group, low‐level group and high‐level group). Semen parameters were evaluated in all subjects. The patients who had not reached spontaneous pregnancy underwent assisted reproductive techniques.

Sperm number was significantly increased after treatment with FSH at doses of at least 200 IU, and the improvement was observed beginning at the third month. The significant improvement in both morphology and forward motility was observed beginning at the fifth month. Moreover, 300 IU rhFSH administration for 5 months could significantly improve the spontaneous pregnancy rate (12/40) and ART pregnancy rate (14/28), while the rates for placebo group were two of twenty‐nine and five of twenty‐seven, respectively. The seminal parameters (total sperm count, sperm concentration, forward motility and morphology) were significantly improved in the normal‐ and low‐level inhibin B groups, but no significant variation was observed in the high‐level group at the end of the study.

The efficacy of FSH treatment was associated with the dose of FSH and duration of treatment, and FSH therapy was more effective in patients with normal level and low level of inhibin B.